While most of what the FDA laid out in a recent draft guidance on the assessment of overall survival in oncology clinical trials was expected, the document still raised one…
GSK and Spero Therapeutics have shared phase 3 results on their antibiotic candidate, revealing that the oral therapy closely matched the intravenous incumbent in a trial that could support filings…
Neuphoria Therapeutics’ lead candidate has failed to improve social anxiety symptoms in a late-stage trial, prompting the biotech to discontinue the program and launch a strategic review of its business.…
Galapagos is planning to wind down its cell therapy business, completing a whiplash change that saw the biotech go from focusing on the modality to ditching it in six months.…
After rejecting Replimune’s melanoma drug RP1 this summer, the FDA has accepted the biotech’s resubmission of an approval application. The federal agency said it expects to reach a decision on…
The U.S. private equity market is showing signs of recovery, with strong deal activity and lower interest rates driving optimism, though exit and fundraising challenges remain. The current conditions are…
As scientific disinformation skyrockets, the Biotechnology Innovation Organization (BIO)—the world’s largest biotech trade association—is aiming to set the record straight on vaccines, rolling out a campaign highlighting the unmistakable value…
BioNTech won’t proceed with further development of its BNT111 cancer vaccine candidate in a specific late-stage refractory melanoma setting, a company spokesperson told Fierce Biotech. The decision to push pause…
Daiichi Sankyo and Merck & Co. have reported midphase ovarian cancer data, clearing the partners to advance the antibody-drug conjugate into the phase 3 part of the trial. The phase…
Roche is forging ahead with plans to seek approval for an eye disease drug candidate despite missing the primary endpoint in one of its phase 3 trials. The Swiss drugmaker…